19090 Federal Register / Vol. 70, No.
69 / Tuesday, April 12, 2005 / Notices
b. Current Budget Period Financial
Progress.
c. New Budget Period Program
Proposed Activity Objectives.
d. Budget.
e. Measures of effectiveness.
f. Additional requested information,
including (1) data related to
performance target goals; (2) data on
progress toward achieving objectives; (3)
an inventory of total individual capacity
building assistance and proactive
training for the reporting period; and (4)
data related to the quality assurance
system.
2. Second trimester interim progress
report shall be due 30 days after the
completion of the first eight (8) months
of the project period. This second
trimester progress report will serve as
your non-competing continuation
application for the next funding cycle.
(See Continuing Application
Requirements provided by Procurement
and Grants Office.) This report must
include elements a–f, as listed in the
first trimester report, and be completed
during this time period (months 5–8).
The report should also include the
following:
a. Base line and actual level of core
performance indicators.
b. Specific guidance, which will be
provided by the CDC three months prior
to the due date.
3. The third trimester progress report
shall be due 30 days after the end of the
budget period. This report must include
elements a–f as listed in the first
trimester report, elements a–b as listed
in the second trimester report, and
completed during this time period
(months 9–12).
4. Financial status report is due no
more than 90 days after the end of the
budget period.
5. Final financial and performance
reports are due no more than 90 days
after the end of the project period.
These reports must be mailed to the
Grants Management or Contract
Specialist listed in the ‘‘Agency
Contacts’’ section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning
this announcement.
For Pre-application Technical
Consultation: Send questions regarding
this application to
DHAPCBAPT@CDC.GOV. You will
receive a response within 24–48 hours.
For general questions, contact:
Technical Information Management
Section, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
GA 30341. Telephone: 770–488–2700.
For program technical assistance,
contact: Gerlinda Gallegos Somerville,
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Public Health Analyst, Centers for
Disease Control and Prevention,
National Center for HIV, STD, and TB
Prevention, Division of HIV/AIDS
Prevention, Capacity Building Branch,
1600 Clifton Road, Mailstop E–40,
Atlanta, GA 30333, Telephone: 404–
639–2918. E-mail address:
DHAPCBAPT@CDC.GOV.
For financial, grants management, or
budget assistance, contact: Roslyn
Curington, Grants Management
Specialist, Centers for Disease Control
and Prevention, Procurement and
Grants Office, 2920 Brandywine Road,
Room 3000, Atlanta, Georgia 30341–
4146. Telephone: 770–488–2767, E-mail
address: zlp8@cdc.gov.
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: www.cdc.gov. Click on
‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements.’’
Dated: April 6, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–7286 Filed 4–11–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–5033–N6]
Medicare Program; Cancellation of the
April 13, 2005 Advisory Board Meeting
on the Demonstration of a Bundled
Case-Mix Adjusted Payment System
for End-Stage Renal Disease Services
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Cancellation of meeting.
SUMMARY: This notice cancels the April
13, 2005 Advisory Board Meeting on the
Demonstration of a Bundled Case-Mix
Adjusted Payment System for End-Stage
Renal Disease (ESRD) Services. We
published the meeting notice in the
Federal Register on March 25, 2005 (70
FR 15343).
DATES: Effective Date: The notice
announcing the cancellation of the
meeting is effective April 12, 2005.
FOR FURTHER INFORMATION CONTACT:
Pamela Kelly by e-mail at
ESRDAdvisoryBoard@cms.hhs.gov or
telephone at (410) 786–2461.
SUPPLEMENTARY INFORMATION: On June 2,
2004, we published a Federal Register
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notice requesting nominations for
individuals to serve on the Advisory
Board on the Demonstration of a
Bundled Case-Mix Adjusted Payment
System for End-Stage Renal Disease
(ESRD) Services. The June 2, 2004
notice also announced the
establishment of the Advisory Board
and the signing by the Secretary on May
11, 2004 of the charter establishing the
Advisory Board. On January 28, 2005,
we published a Federal Register notice
(70 FR 4132) announcing the
appointment of eleven individuals to
serve as members of the Advisory Board
on the Demonstration of a Bundled
Case-Mix Adjusted Payment System for
ESRD Services, including one
individual to serve as co-chairperson,
and one additional co-chairperson, who
is employed by CMS. The first public
meeting of the Advisory Board was held
on February 16, 2005. The second
public meeting of the Advisory Board
scheduled for April 13, 2005 has been
cancelled.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: April 7, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–7408 Filed 4–8–05; 1:51 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cooperative Agreement to Support the
World Health Organization
International Programme on Chemical
Safety
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
I. Funding Opportunity Description
The Food and Drug Administration
(FDA) is announcing its intent to accept
and consider a single source application
for the award of a cooperative agreement
to the World Health Organization
(WHO) to support the International
Programme on Chemical Safety (IPCS).
FDA anticipates providing $90,000
(direct and indirect costs) in fiscal year
2005 in support of this project. Subject
to the availability of Federal funds and
successful performance, 2 additional
years of support up to $90,000 per year
(direct and indirect costs) will be
available. FDA will support the research
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 Federal Register / Vol. 70, No. 69 / Tuesday, April 12, 2005 / Notices
covered by this notice under the
authority of section 301 of the Public
Health Service (PHS) Act (42 U.S.C.
241). FDA’s research program is
described in the Catalog of Federal
Domestic Assistance No. 93.103. Before
entering into cooperative agreements,
FDA carefully considers the benefits
such agreements will provide to the
public.
The cooperative agreement ensures
FDA’s participation and leadership in
important international risk assessment
and standard setting activities for food
ingredients, contaminants, and
veterinary drug residues. The
development of such international
standards provides the public with
greater assurance of the quality and
safety of food sold in the United States.
II. Eligibility Information
Competition is limited to the WHO/
IPCS because it is the parent
organization of the Joint Food and
Agriculture Organization (FAO)/WHO
Expert Committee on Food Additives
(JECFA), which provides scientific
advice to the Codex Alimentarius
Commission (CAC). The international
food standards established by the CAC
are recognized by the World Trade
Organization (WTO) as necessary to
protect public health and presumed to
be consistent with the Sanitary and
Phytosanitary (SPS) Agreement of the
General Agreement on Tariffs and Trade
(GATT). These programs under the IPCS
are the only such programs in existence,
and make the IPCS unique as a
participant in international standard
setting for food ingredients,
contaminants, and veterinary drug
residues. Awarding this cooperative
agreement will help ensure that the risk
assessments provided by the JECFA to
the CAC are science-based, enhance the
safety of food sold in the United States,
and enhance the safety of food additives
and veterinary drug residues in
imported food.
As of October 1, 2003, applicants are
required to have a Dun and Bradstreet
Number (DUNS) number to apply for a
grant or cooperative agreement from the
Federal Government. The DUNS
number is a 9-digit identification
number, which uniquely identifies
business entities. Obtaining a DUNS
number is easy and there is no charge.
To obtain a DUNS number, foreign
applicants should go to http://
www.grants.gov/RequestaDUNS, 4th
paragraph. (FDA has verified the Web
site address, but FDA is not responsible
for any subsequent changes to the Web
site after this document publishes in the
Federal Register.)
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III. Application and Submission
For further information or a copy of
the complete Request for Applications
(RFA) contact Cynthia Polit, Grants
Management Specialist, Division of
Contracts and Grants Management
(HFA–500), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7180, e-
mail: cynthia.polit@fda.gov or
cpolit@oc.fda.gov. This RFA can also be
viewed on Grants.gov under ‘‘Grant
Find.’’ A copy of the complete RFA can
also be viewed on FDA’s Center for
Food Safety and Applied Nutrition Web
site at http://www.cfsan.fda.gov/
list.html.
Dated: April 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7288 Filed 4–11–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0182]
Guidance for Industry and Food and
Drug Administration Staff; Submission
and Resolution of Formal Disputes
Regarding the Timeliness of Premarket
Review of a Combination Product;
Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
and FDA staff entitled ‘‘Submission and
Resolution of Formal Disputes
Regarding the Timeliness of Premarket
Review of a Combination Product.’’ The
Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
delegates to the Office of Combination
Products (OCP) responsibility for
resolving disputes about the timeliness
of premarket review of combination
products. This guidance document
provides information about presenting
requests for resolution of disputes about
the timeliness of premarket review of
combination products.
DATES: Submit written or electronic
comments on agency guidances at any
time. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance document
to the Office of Combination Products
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19091
(HFG–3), 15800 Crabbs Branch Way,
Rockville, MD 20855. Send one self-
addressed adhesive label to assist that
office in processing your requests.
Submit written comments concerning
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Suzanne O’Shea, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, Rockville, MD 20855, 301–427–
1934, FAX: 301–427–1935.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Submission and Resolution of
Formal Disputes Regarding the
Timeliness of Premarket Review of a
Combination Product.’’ In the Federal
Register of May 4, 2004 (69 FR 24653),
FDA issued a notice of availability of a
draft guidance document covering the
same topic. The draft guidance
document was entitled ‘‘Combination
Products, Timeliness of Premarket
Reviews, Dispute Resolution Guidance.’’
MDUFMA delegated to OCP
responsibility for resolving disputes
about the timeliness of reviews of
premarket applications covering
combination products. This guidance
document provides information on how
an applicant submitting an application
covering a combination product can
submit a request that OCP resolve such
a dispute.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on how to present to
OCP disputes pertaining to the
timeliness of reviews of combination
products. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments on the guidance at any time.
Submit two paper copies of any mailed
comments, except that individuals may
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